Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

This was a phase 4, observational, open-label study conducted in participants who were prescribed azithromycin by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Azithromycin for Prophylaxis

Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Azithromycin for Treatment

Participants taking Azithromycin for Treatment according to Japanese Package Insert.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Azithromycin for Prophylaxis

Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Azithromycin for Treatment

Participants taking Azithromycin for Treatment according to Japanese Package Insert.

Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.

Measure Description

Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.

Time Frame

9 years(MAX)

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.

Reporting Groups

Description

Azithromycin for Prophylaxis

Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Azithromycin for Treatment

Participants taking Azithromycin for Treatment according to Japanese Package Insert.

Measured Values

Azithromycin for Prophylaxis

Azithromycin for Treatment

Participants Analyzed [Units: Participants]

391

84

Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. [Units: Events]

37

9

No statistical analysis provided for Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.